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Fast-track equivalent to traditional cardiac rehabilitation? Pilot study outcome
Bellet RN, Francis RL, Jacob JS, Healy KM, Bartlett HJ, Adams L, Morris NR
European Journal of Physiotherapy 2016;18(2):126-136
clinical trial
7/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

The exercise dose required to achieve benefits from cardiac rehabilitation (CR) is unknown and benefits may be independent of exercise supervision frequency. This randomized pilot study examined equivalence in two CR models, hypothesizing <= 10% difference between models. Subjects undertook 6 weeks of supervised low- to moderate-intensity exercise training. Fast-track (n = 25) included once-weekly exercise sessions and a one-off 7 h education session. Traditional (n = 36) included twice-weekly exercise and education sessions. Six-Minute Walk Test distance (6MWD), Timed Up and Go test time (TUGTT), Depression, Anxiety and Stress Scale (DASS-21) score and secondary outcomes were assessed pre-CR, post-CR and 6 months post-CR. Attendance was 100%, 79% and 82%, respectively. Missing data were imputed using last-observation-carried-forward methodology. Although intention-to-treat analysis found minimal between-group differences (7 m, p = 0.76 (6MWD); 0.27 s, p = 0.35 (TUGTT); and 14.6, p = 0.09 (DASS-21)) and similar proportions of subjects achieved a minimal clinically important difference and predicted values for 6MWD and TUGTT post-CR, the effect size was greater for fast-track subjects. A > 10% difference was noted for several secondary outcomes, mostly in favour of the traditional CR model. In conclusion, this pilot study identifies appropriate methodology to assess equivalence in CR models and suggests that one supervised exercise session may be as effective as two sessions for common outcome measurements.

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